DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant’s submission filed on 4/7/2026 has been entered.
Election/Restrictions
Claim 1 is allowable over the prior art. Claims 3-4 and 10, previously withdrawn from consideration as a result of a restriction requirement, requires all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among species A-C and among species 1-2, as set forth in the Office action mailed on 8/5/2024, is hereby withdrawn and claims 3-4 and 10 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 6, 13, 15, and 17-18 are objected to because of the following informalities:
in claim 6, line 3: “the sensed the” should be “the sensed”;
in claim 13, line 15: “both” should be “more”;
in claim 13, line 15: “the” should be inserted before “dose”;
in claim 15, line 3: “the anatomical location” should be “an anatomical location”;
in claim 15, line 5: “a relative position of” should be “a relative position between”;
in claim 17, lines 3-4: “the delivering electrical neurostimulation includes delivering electrical neurostimulation” should be “the delivering of the electrical neurostimulation includes delivering the electrical neurostimulation”; and
in claim 18, line 19: “both” should be “more”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7, 9-11, 13-15, and 17-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “compare the one or more sensed evoked resonant neural activity signals to the reference signals and select a reference signal using a matching criterion” in lines 18-19, but it is not clear if the selection of the reference signal is a result or consequence of the comparison. The recitation itself does not make a causal link between the two actions; however the placement of the two actions in the same indentation suggests that there might be a causal link. Clarification is required.
Claims 2-7 and 9-11 are rejected by virtue of their dependence from claim 1.
Claim 3 recites “a stimulation circuit configured to deliver electrical neurostimulation to initiate the one or more evoked resonant neural activity signals” in lines 2-3, but it is not clear if this recitation is the same as, related to, or different from “a stimulation circuit configured to deliver electrical neurostimulation to initiate one or more evoked resonant neural activity signals representative of neural activity of a subject when connected to an implantable electrode of the one or more implantable electrodes” of claim 1, lines 3-5. Relatedly, it is not clear if the electrical neurostimulation of this recitation of claim 3 is the same as, related to, or different from the electrostimulation of the recitation of claim 1. Clarification on these points is required.
Claim 3 recites “a local evoked resonant neural activity signal at or near a location of the electrical neurostimulation” in lines 4-5, but it is not clear if this recitation is the same as, related to, or different from “one or more evoked resonant neural activity signals representative of neural activity of a subject” of claim 1, lines 3-4. The different phraseology and the claim’s structure suggest that they are different, but a local evoked resonant neural activity signal is an evoked resonant neural activity signal. Clarification is required.
Claim 4 recites “a stimulation circuit configured to deliver electrical neurostimulation to initiate the one or more evoked resonant neural activity signals” in lines 2-3, but it is not clear if this recitation is the same as, related to, or different from “a stimulation circuit configured to deliver electrical neurostimulation to initiate one or more evoked resonant neural activity signals representative of neural activity of a subject when connected to an implantable electrode of the one or more implantable electrodes” of claim 1, lines 3-5. Relatedly, it is not clear if the electrical neurostimulation of this recitation of claim 4 is the same as, related to, or different from the electrostimulation of the recitation of claim 1. Clarification on these points is required.
Claim 4 recites “a network evoked resonant neural activity signal” in lines 4-5, but it is not clear if this recitation is the same as, related to, or different from “one or more evoked resonant neural activity signals representative of neural activity of a subject” of claim 1, lines 3-4. The different phraseology and the claim’s structure suggest that they are different, but a network evoked resonant neural activity signal is an evoked resonant neural activity signal. Clarification is required.
Claim 6 recites “the processing circuitry is further configured to compare the sensed the spontaneous neural activity signal to the reference signals and the selected reference signal is a baseline spontaneous neural activity signal associated with the state of arousal” in lines 2-5, but it is not clear how the comparison between the sensed the spontaneous neural activity signal to the reference signals fits within the processing regime of claim 1. In particular, the recitation of claim 6 recites a step that is not mentioned again in the following steps of determining a depth of the anesthesia and generating an indication. What is the role of the comparison of claim 6 in the processing regime? This issue renders claim 6 indefinite.
Claim 10 recites “the determined correlation” in lines 6-7, but it is not clear if this recitation is the same as, related to, or different from the determined measure of association of claim 10, line 3. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear and/or it should be made clear where and what relevance the determined measure of association and the determined correlation have for the claim’s processing regime.
Claim 13 recites “the one or more sensed evoked resonant neural activity signals” in line 18, but it is not clear if these recitation are the same as, related to, or different from “one or more neural activity signals” that are sensed in claim 13, line 3. If they are the same, “the one or more sensed evoked resonant neural activity signals” in line 18 should both be “the one or more neural activity signals”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). Also, if they are different, it should be made clear where and what relevance the one or more sensed evoked resonant neural activity signals have for the claim’s processing regime.
Claims 14-15 and 17 are rejected by virtue of their dependence from claim 13.
Claim 17 recites “the electrical neurostimulation stimulus” in lines 2-3 in which there is insufficient antecedent basis for this limitation in the claim. Relatedly, it is not clear if this recitation is the same as, related to, or different from “electrical neurostimulation” of claim 13, line 2. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear.
Claim 17 recites “wherein the one or more sensed evoked resonant neural activity signals includes a local evoked resonant neural activity signal” in lines 1-2, but this recitation compounds the indefiniteness issue with respect to “the one or more sensed evoked resonant neural activity signals” in claim 13, line 18. Accordingly, it suffers from the same indefiniteness issue as “the one or more sensed evoked resonant neural activity signals” in claim 13, line 18.
Claim 18 recites “one or more of the type of the general anesthetic drug and the dose of the general anesthetic drug” in lines 13-14, but it is not clear if this recitation is the same as, related to, or different from “one or more of a type of general anesthetic drug and a dose of the general anesthetic drug” in claim 18, lines 7-8. If they are the same, “the” should be inserted before the recitation of lines 13-14. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claims 19 is rejected by virtue of their dependence from claim 18.
Allowable Subject Matter
Claims 1-7, 9-11, 13-15, and 17-19 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and under 35 U.S.C. 101 set forth in this Office action.
The following is an examiner’s statement of reasons for allowance.
U.S. Patent Application Publication No. 2019/0143120 (Sinclair 120)(previously cited) teaches a medical system for coupling to one or more implantable electrodes (the implanted electrodes of Sinclair 120; abstract, paragraphs 0004, 0016, 0033, 0056, 0071, 0140-0142, 0153, 0156, 0163-0168, and 0208-0211 of Sinclair 120; FIGS. 8-9 and 13-14 of Sinclair 120), the system comprising: a sensing circuit configured to sense one or more neural activity signals representative of neural activity of a subject when connected to an implantable electrode of the one or more implantable electrodes (the measurement circuit 96 of Sinclair 120); a memory (the memory 102 of Sinclair 120; paragraphs 0157, 0169, 0182 of Sinclair 120) to store a reference signal (paragraphs 0165-0166 and 0170 of Sinclair 120); and processing circuitry (the processing unit 92 of Sinclair 120) in communication with the sensing circuit and the memory, the processing circuitry configured to: compare the one or more sensed evoked resonant neural activity signals to the reference signal (the comparison of Sinclair 120; paragraphs 0165-0166 and 0170 of Sinclair 120) and generate an indication of the anatomical location corresponding to the reference signal as the location of the implantable electrode (paragraphs 0161, 0165-0166 and 0170-171 of Sinclair 120).
Sinclair 120 teaches that the method and system can be used when a patient is under sedation or general anesthetic during surgery (paragraph 0156 of Sinclair 120). Further, Sinclair 120 teaches that a map of evoked response at different locations may be generated (paragraph 0165 of Sinclair 120). U.S. Patent Application Publication No. 2019/0321106 (Bergman)(previously cited) teaches that tissue maps may include signals associated with anatomical regions and different physiological states, such as sleeping/awareness, which is beneficial to know during surgery (paragraph 0569 and 0572-0575 of Bergman). U.S. Patent Application Publication No. 2021/0236821 (Sinclair 821)(previously cited) teaches that comparing ERNA to references provides a supportive indication of a patient’s consciousness that is beneficial during general anesthesia generally (paragraph 0246 of Sinclair 821). Thus, ERNA are also the type of signals associated with different physiological states. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have each reference signal associated with a specific anatomical location and representative of the depth of sleep and/or awareness of the patient since (1) it provides more accurate results when determining location and (2) it provides a level of awareness of the patient during surgery. Thus, the combination teaches or suggest that the reference signal is representative of a local or network neural activity signal associated with a state of arousal at or near an anatomical location of the subject and the step of determine a depth of anesthesia of the subject according to the comparison of the one or more sensed neural activity signals and the reference signal.
U.S. Patent Application Publication No. 2020/0327995 (Ye)(previously cited) discloses a method including the steps of acquiring an electroencephalogram signal by means of an electroencephalogram sensor; selecting a target anesthesia depth model from an anesthesia depth model database according to the type of a drug for anesthesia, each anesthesia depth model of the anesthesia depth model database being trained according to a specific drug type, a corresponding electroencephalogram signal, and a marked anesthesia depth; and obtaining an anesthesia depth value on the basis of the target anesthesia depth model and the electroencephalogram signal (Abstract of Ye). However, Ye does not teach or suggest that such a regime is applicable to the neural activity signals, such as the signals of Sinclair 120.
With respect to claim 1, the prior art (including Ye) does not teach or suggest “a memory to store an anesthesia response map that includes reference signals stored in association with anatomical locations and with one or more of a type of general anesthetic drug and a dose of the general anesthetic drug… the processing circuitry configured to…compare the one or more sensed evoked resonant neural activity signals to the reference signals and select a reference signal using a matching criterion; determine a depth of anesthesia of the subject corresponding to the selected reference signal” along with the other features of claim 1.
Claims 2-7 and 9-11 are allowable by virtue of their dependence from claim 1.
With respect to claim 13, the prior art (including Ye) does not teach or suggest “receiving anesthesia state information for the subject including an indication of the one or more of the type of the general anesthetic drug and the dose of the general anesthetic drug; matching the one or more sensed neural activity signals to select a reference signal of the multiple stored reference signals, wherein the one or more sensed neural activity signals are only compared to those reference signals of the multiple stored reference signals corresponding to the indication of the one or both of the received type of the general anesthetic drug and dose of the general anesthetic drug; determining a depth of anesthesia of the subject corresponding to the one or more sensed evoked resonant neural activity signals and the selected reference signal” along with the other features of claim 13.
Claims 14-15 and 17 are allowable by virtue of their dependence from claim 13.
With respect to claim 18, the prior art (including Ye) does not teach or suggest “a memory to store multiple reference signals in an anesthesia response map in association with respective anatomical locations and with one or more of a type of general anesthetic drug and a dose of the general anesthetic drug…the processing circuitry configured to: receive anesthesia state information for the subject including an indication of one or more of the type of the general anesthetic drug and the dose of the general anesthetic drug…compare the one or more sensed evoked resonant neural activity signals to those reference signals of the multiple reference signals corresponding to the indication of the one or both of the type of the general anesthetic drug and the dose of the general anesthetic drug; match the one or more sensed evoked resonant neural activity signals to select a reference signal of the multiple reference signals; determine a depth of anesthesia of the subject corresponding to the one or more sensed evoked resonant neural activity signals and the selected reference signal” along with the other features of claim 18.
Claim 19 is allowable by virtue of their dependence from claim 18.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
The Applicant’s arguments filed 3/16/2026 have been fully considered.
Claim objections
There are new grounds of claim objections.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
The Applicant did not address, by amendment or argument, the indefiniteness issue with respect to “compare the one or more sensed evoked resonant neural activity signals to the reference signals and select a reference signal using a matching criterion” in claim 1, lines 18-19. The use of the word “and” does not establish if the selection of the reference signal is a result or consequence of the comparison. However, the placement of the two actions in the same indentation suggests that there might be a causal link. If there is a causal link, the Examiner suggests that the recitation recite “compare the one or more sensed evoked resonant neural activity signals to the reference signals [[and]] so as to select a reference signal using a matching criterion”.
The Applicant did not address, by amendment or argument, the indefiniteness issue with respect to “the one or more sensed evoked resonant neural activity signals” in claim 13, line 18. The Examiner cannot find a reason to withdraw the rejection.
The Applicant did not address, by amendment or argument, the indefiniteness issue with respect to “the electrical neurostimulation stimulus” in claim 17, lines 2-3. The Examiner cannot find a reason to withdraw the rejection.
The Applicant did not address, by amendment or argument, the indefiniteness issue with respect to “one or more of the type of the general anesthetic drug and the dose of the general anesthetic drug” in claim 18, lines 13-14. The Examiner cannot find a reason to withdraw the rejection.
35 U.S.C. 101
In view of the claim amendments filed on 3/16/2026, the rejections under 35 U.S.C. 101 have been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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